Most Commonly Reported Side EffectsPain in the knee or at the injection site; stiffness, swelling or warmth around the knee; arthritis; inflammation; fluid build-up around the joint; limping or other changes in the way a patient walks

Synvisc-One Knee Injection Complications

Synvisc-One knee injection complications range from joint pain to infections. The more common reactions to the arthritis treatment aren’t usually serious and tend to go away relatively soon after injection. However, patients who received contaminated gel needed to be treated in a hospital.

Most Commonly Reported Side EffectsPain in the knee or at the injection site; stiffness, swelling or warmth around the knee; arthritis; inflammation; fluid build-up around the joint; limping or other changes in the way a patient walks

About 6 percent of people injected with Synvisc-One during clinical trials reported some type of side effect. Reactions to the arthritis gel generally went away on their own or with minimal treatment.

According to the drug’s maker, side effects sometimes seen after injection include joint pain and swelling. A contaminated batch of Synvisc-One knee injections led to an increase in reported complications in 2017.

Common Side Effects

The package insert for the arthritis injections says the most commonly reported problems associated with them include pain, swelling, heat, redness and fluid build-up around the knee. The manufacturer says these reactions are usually mild and don’t last long.

They are typically treated by resting and applying ice to the affected knee. Sometimes, it’s necessary to take pain relievers such as acetaminophen or non-steroidal anti-inflammatory medications. A doctor may decide to inject steroids or remove fluid from the knee joint.

Rare cases of knee joint infections have also been reported, according to the manufacturer. Rare complications discovered after the injections were on the market include:

Rash

Hives

Itching

Fever

Nausea

Headache

Dizziness

Chills

Muscle cramps

Paresthesia

Peripheral edema

Malaise

Respiratory difficulties

Flushing and facial swelling

The label says there have been rare reports of thrombocytopenia, a condition in which blood has a lower than normal number of platelets. Platelets are blood cell fragments that stick together to form clots and stop bleeding.

Patients and doctors have also reported reactions involving hypersensitivity to the injections, including severe allergic responses.

Contaminated Gel Complications

Sanofi Genzyme saw a spike in reported complications from its Synvisc-One knee injections in late 2017. The reports often mirrored common side effects of the arthritis gel. But the number of complaints was higher than expected. In some cases, patients reported more severe symptoms.

The company investigated and discovered gram-negative bacteria had contaminated some syringes. Gram-negative bacteria include E. coli and Salmonella as well as several other difficult-to-treat bacteria. Sanofi Genzyme did not name the exact bacteria that contaminated the syringes.

The bacteria can cause pneumonia and bloodstream, wound and surgical-site infections. Some are resistant to antibiotics. This can force health care providers to rely on older drugs for treatment. But older antibiotics may have toxic side effects.

The manufacturer recalled 18,000 syringes in December 2017. The recall notice warned that the affected lot “may result in the risk of infection.”

The side effects from the contaminated lot mimicked typical complications. But some patients reported issues that required outpatient, emergency room and hospital treatment.

What To Do

If you have questions about the Synvisc-One recall, call Sanofi Medical Information Services at 1-800-633-1610, and select option 1.

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member

Centers for Disease Control and Prevention Health Literacy certificates

Original works published or cited in Washington Examiner, MedPage Today and The New York Times

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